AS-OBGYN Information System version 7.824.x recall: Software Issue
AS-OBGYN Information System version 7.824.x
Why was AS-OBGYN Information System version 7.824.x recalled?
Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the AS system
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version 7.824.x
- Product
- AS-OBGYN Information System version 7.824.x
- Recalling firm
- AS Software, Inc.
- Quantity
- 52 systems
- Distribution
- US Nationwide.
- Recall date
- October 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)